Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project

Diabetes Mellitus Clinical Trial

— ITADI  

Official title:

Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954967
• Other study ID #: PI08/90345
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2018
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study addresses an important problem in public health, smoking in diabetics. The morbidity and mortality observed in diabetics is linked to macro and microvascular problems. The consumption of tobacco has a multiplying effect on these vascular problems in diabetics. This study aims to evaluate the effectiveness of an intensive intervention in tobacco addiction in diabetic patients in primary care.

Description:

Other objectives of the study are:

1. To study the effectiveness of an intensive smoking cessation intervention in the evolution of the phases of change, as based on the Prochaska and DiClemente model, in diabetic patients attended in primary care.

2. To evaluate the effectiveness of an intensive smoking cessation intervention in the evolution of tabacco consumption in diabetic patients attended in primary care.

3. To quantify the time spent in the intensive smoking cessation intervention compared with the usual care in primary care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: September 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• diabetic patients who are active smokers

• over the age of 14

• receive routine care in their respective health center

Exclusion Criteria:

• patients with communication difficulties (cognitive deterioration, language barrier)

• patients who normally receive their habitual care in a different health center

• patients with terminal diseases, psychiatric diseases that are unstable, or with addictions to other substances

• patients that are already receiving treatment to quit smoking at the time of recruitment

• patients that are difficult to locate during the study period

• patients that refuse to participate in the study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Smoking Cessation

Intervention

Behavioral:
• Lifestyle Counseling
The intervention is based on lifestyle advice, motivational interviewing and the use of medications, using the Clinical Practice Guidelines of the Catalan Institute of Health. Health professionals in the intervention group receive a training on the abovementioned techniques.

Locations

Country	Name	City	State
Spain	IDIAP Jordi Gol	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Consorci Sanitari de Terrassa, INSTITUT CATALA DE LA SALUT

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less		12 months after initiation of study
Secondary	Evolution of the phases of change of the Prochaska and DiClemente model		12 months after initiation of the study
Secondary	Number of cigarettes per day		12 months after initiation of the study
Secondary	Total time (minutes) spent in the intensive smoking cessation intervention		12 months after initiation of the study